Xarelto

Medicinal product

(Invented) name

Xarelto

Active substance (s)

Rivaroksabanas

Strength

1 mg/ml

Pharmaceutical form

granulės geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AF01, Rivaroxaban

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2008-09-30

Date of renewal

Documents

Xarelto paciento kortele.pdf

Xarelto mokomoji medziaga sveikatos prieziuros specialistams.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Granules for oral suspension. Following reconstitution the oral suspension contains	1 ml
Rivaroksabanas	1 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
105678	91778	1091778	buteliukas	100 ml, vandens švirkštas (50 ml), švirkštai (2x1 ml) ir adapteris N1	Vaikams, sveriantiems <4 kg	Receptinis	EU/1/08/472/050	Netiekiama	-	-	No	-	-
105679	91779	1091779	buteliukas	250 ml, vandens švirkštas (100 ml), švirkštai (2x5 ml ir 2x 10 ml) ir adapteris N1	Vaikams, sveriantiems >=4 kg	Receptinis	EU/1/08/472/051	Netiekiama	2025-09-02	2025-09-15	No	-	-

Stadijos

Data	Stadija
2008-09-30	Registruotas